NCT01588834已完成不适用
Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 2 - Premenopausal Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- proportion of epithelium vs stroma
研究概览
简要总结
The investigators hypothesize that knowledge of the functional behavior of areas of mammographic density will enable more specific identification of dense tissue at-risk for breast cancer, ultimately providing predictive information on an individual's risk of developing breast cancer.
详细描述
The specific aims are:
- In women with increased mammographic density (MD), determine the histological characteristics of functionally dense tissue compared to that of non-functionally dense tissue via core-needle biopsy of the breast.
- In women with increased mammographic density (MD), determine the correlations between the total percent area of functional density (FD) on MBI, percent density of MD on mammogram, and histological characteristics of dense tissue
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ages 40 - 55 years
- •Considered premenopausal or peri-menopausal
- •Screening mammogram performed at Mayo Clinic Rochester within one year prior to the current MBI study which demonstrates
- •Negative/benign assessment (BIRADS category 1-2) or Additional imaging recommended (BIRADS category 0), where the subsequent diagnostic workup results in a final negative/benign assessment (BIRADS category 1-2).
- •No proliferative benign lesions (e.g. fibroadenomas) identified
- •Heterogeneously dense or extremely dense parenchyma (BIRADs density category 3 or 4)
- •MBI performed less than 3 days prior to biopsy demonstrating either marked FD or photopenic FD in an area of mammographically dense tissue amenable to biopsy.
- •No use of exogenous hormonal drugs (e.g. hormonal contraceptives or sex steroid hormones) within six months prior to study biopsy
- •Negative pregnancy test or surgically sterilized (for patients in whom a study MBI will be performed)
- •Exclusion criteria:
- •Using any estrogen receptor modulating drugs (e.g., tamoxifen, raloxifene) or any aromatase inhibitors within six months prior to study biopsy.
- •Prior diagnosis of bilateral breast cancer.
- •Diagnosis of breast cancer in either breast within 3 years prior to study MBI.
- •Diagnosis of any cancer, except breast cancer (see #3) or non-melanomatous skin cancer, for which patient has not been disease free for at least 5 years.
- •Current breast symptoms
- •Breast implants
- •Known allergy to local anesthetic.
- •History of bleeding complications from prior interventions
- •Current use of anticoagulants (e.g., Coumadin or other blood thinners)
- •Major medical condition
排除标准
- 未提供
结局指标
主要结局
proportion of epithelium vs stroma
时间窗: within 3 days of functional density assessment on MBI
次要结局
- Ki-67 cellular proliferation index(within 3 days of functional density assessment on MBI)
- Degree of lobular involution(within 3 days of functional density assessment on MBI)
研究者
Carrie Hruska
Principal Investigator
Mayo Clinic
研究点 (1)
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